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Head of clinical evaluation

Sant Vicenç dels Horts
iVascular
Publicada el 10 diciembre
Descripción

PpAt iVascular, we are dedicated to the design, manufacturing, production, and commercialization of medical devices for the treatment of cardio, neuro, and endovascular diseases and to become a reference in the vascular field by enhancing the value of technology and innovation. /p pWe are a national company founded in 2010 in Barcelona (Spain) in a phase of growth and international expansion, with subsidiaries already established in Europe, Latin America, Canada, and China, and a team of more than 550 employees covering the entire manufacturing process through vertical integration. /p pWe are currently seeking a passionate and experienced Head of Clinical Evaluation to join our Clinical team at our site in Sant Vicenç dels Horts (Barcelona). /p pYou will be responsible for leading the Clinical Evaluation unit, driving the company’s clinical strategy. You will oversee the development, writing and supervision of all key clinical documentation, ensuring high-quality systematic literature reviews and the preparation, review and approval of Clinical Evaluation Reports, always in full compliance with the European Medical Device Regulation. /p h3KEY RESPONSIBILITIES /h3 ul liLead the Clinical Evaluation unit, managing the team and ensuring alignment with the company’s overall clinical strategy. /li liOversee and execute comprehensive systematic literature reviews, ensuring robust methodology, full traceability and the appropriate use of specialized databases. /li liCritically appraise all available clinical evidence —both internal data and published literature—to support well-founded conclusions on device safety and performance. /li liDirect and contribute to the development, writing, validation and approval of Literature Search Reports and Clinical Evaluation Reports (CERs). /li liPrepare key clinical documentation, including Literature Search Reports, Clinical Evaluation Reports, PMCF Reports and SSCPs. /li /ul h3DESIRED PROFILE /h3 ul liMedical degree (MD) is required, preferably (valuable) with specialization in cardiovascular, neurovascular or peripheral vascular medicine. /li liHigh level of English and Spanish. /li li10 years of experience with EU MDR 2017/745, including extensive authorship, review and approval of CERs and clinical documentation. /li liStrong experience authoring PMCF Reports, SSCPs, Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER). /li liValuable experience with ISO 14155 and other clinical investigation standards. /li liStrong expertise writing, literature appraisal and systematic literature searches. /li liFamiliarity with reference management tools (Zotero, Mendeley, etc.). /li /ul h3WHAT WE OFFER /h3 ul liPermanent and stable contract in a project with high global impact and expanding internationally. /li liProfessional and personal development in a vibrant, dynamic, and youthful environment. /li liCompetitive salary tailored to your experience, along with an attractive benefits package. /li liFlexible working hours to support a healthy work-life balance. /li liFlexible compensation (meal vouchers, transportation, and childcare assistance). /li liAccess to our iWellness program: gym and physiotherapist on site. /li liCorporate events and gifts. /li liSubsidized on-site company cafeteria. /li /ul /p #J-18808-Ljbffr

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